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Development of a Reference Material for Characterizing Adenovirus Vectors

by Beth Hutchins, PhDVolume 1, Issue 1 (March 2002)

The development of reference testing reagents has been used successfully in the past to standardize measurements among laboratories, particularly for biological products such as recombinant cytokines. This approach was recommended by many parties with a stake in adenovirus vector delivery in order to address the fact that particle units and infectious units are not standardized in the field. This has made interpretation of preclinical and clinical data, as it relates to the amount of adenovirus vector administered, difficult to compare across the field. An Adenovirus Reference Material is being developed to define the particle unit and infectious unit for adenovirus gene vectors, and create a commonality for comparisons, especially for data related to vector safety...

We have developed a procedure for large-scale enrichment, growth and harvesting of T cells suitable for adoptive immunotherapy. In two recently completed clinical trials, we investigated the feasibility of immune reconstitution in patients with HIV infection, or with relapsed/refractory Non-Hodgkin's Lymphoma (NHL) following infusions of autologous activated CD4+ T cells or CD4+/CD8+ T cells. Autologous T cells were activated via CD3/CD28 stimulation, ex vivo, and were then reinfused...

Development of Capabilities for Small-Scale Virus Fills

Introgen Therapeutics has been producing clinical-grade adenoviral vectors in scaled-up processes, in cGMP facilities, for over five years. Semi-automated hand filling, using a Watson-Marlow 505Di/L pump, has been used over this period to fill batch sizes of up to 2 liters of adenovirus. While this procedure has been robust and demonstrated a high level of sterility assurance through regularly scheduled media fill studies and product testing, the firm needed to move to the next level of fill sizes. Anticipating up to 10,000 fills in 3 mL vials, Introgen has worked in collaboration with M&O Perry Corp. to develop an automated fill capability that utilizes the same base procedure but in an automated fashion...

Development of a Stable Adenoviral Vector Formulation

A formulation for purified adenoviral vectors was developed that provides stability through freeze-thaw stress and long-term storage at non-frozen temperatures. To evaluate the various test conditions, a panel of stability indicating methods was assembled, which included laser light scattering, HPLC, and transgene expression assays. Preformulation studies were conducted, and the effects of buffer species, pH, cryoprotectants, and salts upon adenoviral vector stability were determined...

Local Gene Therapy for Lumbar Spine Fusion

by Jeffrey C. Marx, PhDVolume 1, Issue 1 (March 2002)

In orthopedic procedures, there is a need to form new bone to repair and fill defects arising from either trauma or degenerative disease. The current standard treatment utilizes an autograft, usually from the iliac crest, which results in a second surgical site, weakness in the harvest or donor harvest area, and additional patient morbidity. The goal of our research is to employ a local, ex vivo, gene therapy to obviate the need for autograft in spine fusion procedures. The LIM Mineralization Protein (LMP-1) is a novel intracellular protein capable of inducing bone formation in vitro and in vivo. In this article, I will outline a rapid protocol, whereby buffy coat cells, isolated from autologous peripheral blood, are transduced with an adenoviral vector encoding the LMP-1 gene. These transduced cells are then implanted on a collagen carrier to promote posterolateral arthodesis...

Cellular Therapy: From the Research Laboratory to the Manufacturing Facility

by Linda LemieuxVolume 1, Issue 1 (March 2002)

As you stand on the brink of finalizing your first Investigational New Drug (IND) application for a cellular therapy product, there is always the question looming in the back of your mind. "What did we forget?" Hopefully, the answer is "Nothing." However, it is always good to undergo a review of the standard systems needed in order to transition from research to clinical manufacturing. This article describes an overview of the basic regulatory guidelines and quality systems necessary to begin clinical trials under the regulations of the Food and Drug Administration. However, this should only be considered a guideline, as it does not necessarily address the standards of other regulatory agencies. The investigational product, the clinical indication, and the manufacturing materials used in the investigational product can also change the regulatory requirements needed to proceed with the initiation of clinical trials...